Nanjing First Hospital, Nanjing Medical University
Phase
Not applicable
Started
2024-02-20
Last updated
2024-03-12
Condition(s) studied
Bone LesionCartilage DegenerationOsteo Arthritis KneeBone FractureBone InjuryBone Loss
Investigational drug(s) / intervention(s)
Commercial bone implant product GroupMirco-structured Bioceramic Group
Commercial bone implant product Group: Commercial bone implant product Group with a smooth surface （without particular microstructures）.
Mirco-structured Bioceramic Group: β-tri-Calcium phosphate with microstructures such as grooves, patterns and so on.
Study summary
The purpose of this study is to demonstrate the effect of bioceramic implants on the repair of human bone defects, and to explore the application of bioceramic materials in bone defects, bone implantation, and bone fusion. The surface microstructure of β-tricalcium phosphate bioceramic implants can be effectively controlled to guide the regeneration of bones, promote the restoration of bones, accelerate the speed of recovery, and improve bone quality, which is of great clinical and social significance.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
1. Patients who voluntarily take the test and sign the informed consent form;
2. Patients aged 18-65 years old with no history of allergies;
3. Patients able to communicate well with the investigator and follow the requirements of the entire trial.
Exclusion Criteria:
1. Patients who refuse to sign the informed consent form to participate in the trial;
2. Patients who are not in the age range of 18 to 65 years;
3. Patients with diseases unsuitbale for the trial: history of allergies, severe cardiopulmonary disease, coagulation dysfunction, Alzheimer's disease, cerebral atrophy, acute phase or sequelae of cerebrovascular disease, cognitive impairment;
4. Patients in the acute phase of local or systemic bacterial infections;
5. Patients who cannot cooperate with the operation and evaluate the effect;
6. Other conditions that are considered inappropriate by the investigator to participate in the study.
Primary outcome measure(s)
Quality of life (SF-36) — 12 months SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and have been widely used.
Level of bone healing — 12 months X-ray, CT and MRI images would be used to evaluate the efficacy of bone healing.
Trial sites (1)
Facility
City
Region
Status
Nanjing First Hospital
Nanjing
Jiangsu
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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